Overview

B. Braun Medical, Inc.Company: B. Braun US Pharmaceutical Manufacturing LLCJob Posting Location: Irvine, California, United StatesFunctional Area: QualityWorking Model: OnsiteDays of Work: Friday, Thursday, Wednesday, Tuesday, MondayShift: 5X8Relocation Available: NoRequisition ID: 12955B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap and CAPS .Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit Position SummaryThe Quality Investigator is responsible for leading and documenting investigations related to product, process, supplier, customer, and manufacturing quality issues. This role partners cross-functionally with Quality Engineering, Manufacturing, Quality Operations, Regulatory Affairs, Supplier Quality, and Technical Services teams to identify root causes, implement effective corrective and preventive actions (CAPA), and ensure compliance with company procedures and applicable regulatory requirements.The ideal candidate possesses strong analytical skills, investigation experience, and a thorough understanding of quality systems, risk management, and continuous improvement methodologies. Key ResponsibilitiesQuality InvestigationsLead and document nonconformance, deviation, complaint, CAPA, and quality event investigations.Conduct comprehensive root cause analyses using tools such as:5 WhysFishbone (Ishikawa) DiagramsFault Tree AnalysisPareto AnalysisContradiction MatrixCause and Effect MatrixDMAIC methodologiesEvaluate quality data, manufacturing records, testing results, and process trends to identify potential causes and contributing factors.Ensure investigations are completed accurately, thoroughly, and within established timelines.Corrective and Preventive Actions (CAPA)Develop and recommend effective corrective and preventive actions based on investigation findings.Collaborate with functional teams to implement CAPAs and verify effectiveness.Monitor CAPA progress and ensure timely closure.Quality Systems ComplianceEnsure investigations comply with internal quality procedures and applicable regulatory requirements.Support internal, customer, and regulatory audits by providing investigation records and evidence of compliance.Assist in maintaining inspection readiness and audit preparedness.Data Analysis & TrendingAnalyze quality metrics and trends to identify recurring issues and systemic risks.Generate investigation summaries, management reports, and trend analyses.Support continuous improvement initiatives based on quality data insights.Cross-Functional CollaborationPartner with Manufacturing, Engineering, Supply Chain, Supplier Quality, Regulatory Affairs, and Quality Operations teams to resolve quality issues.Facilitate investigation meetings and communicate findings to stakeholders.Provide guidance on investigation methodologies and documentation best practices.Continuous ImprovementParticipate in process improvement projects aimed at reducing defects, improving product quality, and increasing operational efficiency.Recommend enhancements to quality systems, procedures, and workflows.Support lessons-learned activities and knowledge-sharing initiatives. QualificationsEducationBachelor's degree in Engineering